Hepatitis B Virus
Conditions
Brief summary
The purpose of this study is to evaluate the dosages of recombinant human serum albumin/interferon alpha2b fusion protein injection on HBV subjects. The secondary purposes is to get the PK/PD data in recombinant human serum albumin/interferon alpha2b fusion protein injection on HBV subjects.
Detailed description
This is an open-label study that will be conducted at three sites in China to characterize the PK/PD profile, safety and tolerability of Recombinant Human Serum Albumin/interferon alpha2b Fusion Protein in HBV subjects. Subjects will receive a single dose of Recombinant Human Serum Albumin/interferon alpha2b Fusion Protein or active comparator Pegasys at Day 0. A multipule-dose administration in HBV subjects will last 12 weeks after four weeks washout period.
Interventions
BIOLOGICALHuman Serum Albumin/interferon alpha2b fusion protein
In experiemental groups, each subject will recieve 600,750,900mg once per two weeks during multiple dose period.
BIOLOGICALPegasys
In comparator group, each subject will recieve 180mcg once per week.
Sponsors
Tianjin SinoBiotech Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* HBV patients who have positive HBeAg or HBeAb * Must be healthy males or females between 18 to 60 years old * Must have a body mass index (BMI) of 18 to 30 kg/m2 * HBV DNA≥2000 IU/mL * ALT≥1.3 ULN and ≤10 ULN
Exclusion criteria
* Administrated a nucleoside analogues (acid) or interferons against hepatitis B virus drugs, immunosuppressants, immune regulator before 6 months;Or any other against hepatitis b virus therapy at the same time. * Participated in other clinical trials within a month. * Allergic to interferon. * T-Bil ≥2 ULN. ALB\<35g/L. PT≥4s. * Positive HCV-Ab,HEV-Ab,EBV-Ab,CMV-Ab,TPPA,HIV-Ab. * Organ transplant patients, except cornea or hair transplantation. * Other hepatopathy exclude NAFLD . * Drug addiction or alcohol dependence. * Malignancy(except cured cervical carcinoma in situ, BCC, squamous cell carcinoma) except liver history. * Serious retinal disease. * Active hemorrhagic disease or severe hematopoietic dysfunction or blood coagulation disorder. * Autoimmune disease. * Uncontrolled diabetes or thyroid disease or beyond grade 2 blood pressure. * WBC\<3×109/L or ANC\<1.5 ×109/L or PLT\<90 ×109/L or HGB\<ULN. * HCC or AFP\>100ng/mL. * Chronic kidney disease or sCr\>ULN. * Lactating women or pregnancy. * Cardiovascular and cerebrovascular events within 6 months. * Neurological or psychiatric disease or family history.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the rates of subjects with the level of HBVDNA≤0 IU/mL after treatment | 17 weeks | HBV DNA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the rates of HBV DNA level decrease by more than 2log10 at the end of 4 weeks and after treatment | 4 weeks and 17 weeks | HBV DNA |
| the recovery rates of ALT after treatment | 17 weeks | ALT |
| the negative conversion rates of HBsAg/HBeAg and HBeAg seroconversion rates after treatment | 17 weeks | HBsAg/HBeAg |
| the rates of HBsAg decrease from baseline after treatment | 17 weeks | HBsAg |
Countries
China
Outcome results
None listed